Overview
Principal investigator
Eligibility criteria
Inclusion Criteria:
* Providing written informed consent
* Weight at least 45 kg
* Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
* Diagnosis in the last 30 years
* Positive anti-Ro/SSA antibody test
* Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
* Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
Exclusion Criteria:
* Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
* Uncontrolled hypothyroidism or severe fibromyalgia
* New medications or change in medications in the last 4 weeks for pSS symptoms
* Receipt of other prohibited medications
* Apheresis or blood donation
* Allergic reaction to RSLV-132 or biologic therapy
* Clinically significant infection in last 30 days
* Participation in another clinical study
* Malignancy in last 5 years
* Positive test for HIV or hepatitis
* Major surgery in last 30 days or anticipated surgery during the study
* Pregnancy or breast feeding
* Laboratory blood tests outside of specified ranges
* Other medical conditions or medications that would make the participant unsuitable
* Providing written informed consent
* Weight at least 45 kg
* Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
* Diagnosis in the last 30 years
* Positive anti-Ro/SSA antibody test
* Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
* Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
Exclusion Criteria:
* Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
* Uncontrolled hypothyroidism or severe fibromyalgia
* New medications or change in medications in the last 4 weeks for pSS symptoms
* Receipt of other prohibited medications
* Apheresis or blood donation
* Allergic reaction to RSLV-132 or biologic therapy
* Clinically significant infection in last 30 days
* Participation in another clinical study
* Malignancy in last 5 years
* Positive test for HIV or hepatitis
* Major surgery in last 30 days or anticipated surgery during the study
* Pregnancy or breast feeding
* Laboratory blood tests outside of specified ranges
* Other medical conditions or medications that would make the participant unsuitable
Participate in this trial
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I'm Interested In ParticipatingFor Referring Providers
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